Edwards Certitude Delivery System 9630TA26Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00690103201192), received between Apr 23, 2021 and May 21, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (8 reports).

3 other recalls cover devices cleared under the same FDA submission (P140031); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A LEFT TRANSAPICAL TAVR PROCEDURE WITH A 26MM SAPIEN 3 ULTRA VALVE, THE BALLOON ON THE 26MM CERTITUDE DELIVERY SYSTEM RUPTURED AT THE END OF VALVE DEPLOYMENT, BLOOD WAS SEEN IN THE SYRINGE. THE VALVE WAS FULLY DEPLOYED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242877 ↗
• MalfunctionMay 18, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), A DEVICE-RELATED EVENT OCCURRED DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE INVOLVING A 26 MM SAPIEN 3 ULTRA VALVE DELIVERED VIA A CATHETER-BASED DELIVERY SYSTEM. THE PROCEDURE WAS PERFORMED VIA LEFT CAROTID ACCESS IN A NATIVE TRICUSPID AORTIC VALVE. DURING VALVE DEPLOYMENT, THE DELIVERY SYSTEM BALLOON RUPTURED DURING INFLATION WHEN THE BALLOON WAS FULLY EXPANDED. THE VALVE WAS ABLE TO BE FULLY DEPLOYED, AND THE DEVICE WAS SUCCESSFULLY IMPLANTED. BLOOD WAS OBSERVED IN THE INFLATION SYRINGE AT THE TIME OF THE EVENT. NO LEAKAGE FROM THE DELIVERY SYSTEM WAS OTHERWISE NOTED, AND NO DAMAGE WAS IDENTIFIED TO OTHER EDWARDS DEVICES USED DURING THE PROCEDURE. THERE WAS NO REPORTED DIFFICULTY WITH WITHDRAWAL OF THE DELIVERY SYSTEM. ADDITIONAL PROCEDURAL DETAILS INCLUDE THAT NO PRE-DILATION (BAV) WAS PERFORMED PRIOR TO IMPLANTATION, AND APPROXIMATELY 2 CC OF ADDITIONAL VOLUME WAS ADDED TO THE BALLOON PRIOR TO INFLATION. VALVE ALIGNMENT WAS NOT PERFORMED IN A STRAIGHT SEGMENT OF THE ANATOMY. THE ANNULUS DEMONSTRATED MODERATE CALCIFICATION, INCLUDING CALCIUM EXTENDING FROM THE ANNULUS INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210463 ↗
• MalfunctionOct 23, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, A PATIENT UNDERWENT A TRANSAORTIC TAVR PROCEDURE WITH A 26MM SAPIEN 3 ULTRA VALVE IN AORTIC POSITION. DURING THE PROCEDURE, THE CERTITUDE DELIVERY SYSTEM BALLOON HAD RUPTURED AT THE END OF INFLATION. THE VALVE WAS SUCCESSFULLY IMPLANTED WITH NO MAJOR VASCULAR COMPLICATIONS. AS PER FOLLOW-UP WITH THE FCS, THIS WAS A DIRECT AORTIC APPROACH WITH EXISTING CUTDOWN. A TWO-STAGE DEPLOYMENT WAS SUGGESTED, BUT THE PHYSICIAN PROCEEDED WITH FULL VOLUME, AND THE VALVE APPEARED FULLY EXPANDED ON FLUOROSCOPY AND ECHOCARDIOGRAPHY. THE VALVE WAS ABLE TO BE FULLY DEPLOYED. NO EXTRA VOLUME WAS ADDED PRIOR TO INFLATION. BLOOD WAS NOT SEEN IN THE SYRINGE, AND VALVE ALIGNMENT WAS PERFORMED WITHOUT DIFFICULTY IN A STRAIGHT SECTION. WITHDRAWAL OF THE DELIVERY SYSTEM WAS CHALLENGING, AND THE SYSTEM COULD NOT BE PULLED BACK INTO THE SHEATH. NO DAMAGE WAS NOTED TO OTHER EDWARDS DEVICES, AND THERE WERE NO PATIENT INJURIES OR COMPLICATIONS. THE PATIENT WAS STABLE AND DISCHARGED. THE PERCEIVED ROOT CAUSE WAS HEAVY STJ CALCIUM. AS PER FOLLOW-UP WITH THE VCC, THE PATIENT DID VERY POORLY POST TAVR AND PASSED AWAY ON POST OP DAY 3. THE PRESUMED CAUSE OF DEATH WAS NOTED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369702 ↗
• InjuryMay 19, 2025Burst Container or Vessel; Material Fragmentation; Difficult to Remove; Burst Container or Vessel; Material Fragmentation; Difficult to Remove

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING THE TRANSAORTIC TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA VALVE, THE 26 MM CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED ON SINOTUBULAR JUNCTION (STJ) CALCIUM WHEN IT WAS AT FULL INFLATION. THE DELIVERY SYSTEM HAD BEEN NOMINALLY PREPPED. UPON WITHDRAWAL OF THE DELIVERY SYSTEM THROUGH THE SHEATH, THE RUPTURED BALLOON "UMBRELLAED" AROUND THE SHEATH WHICH RESULTED IN DIFFICULTY REMOVING THE DELIVERY SYSTEM. SUBSEQUENTLY, THE DELIVERY SYSTEM AND SHEATH WERE ABLE TO BE REMOVED AS A UNIT. THE BALLOON WAS NOTED TO BE IN SEVERAL PIECES. THE LARGER HOLE MADE IN THE AORTA WAS REPAIRED UPON THE REMOVAL OF ALL THE DEVICES. THE PATIENT TOLERATED THE PROCEDURE WELL. ADDITIONAL INFORMATION WAS PROVIDED REVEALING THE VALVE WAS BELIEVED TO BE FULLY DEPLOYED AND AS A RESULT, A POST-DILATION WAS NOT PERFORMED. ALTHOUGH THE BALLOON WAS NOTED TO BE IN SEVERAL PIECES, IT APPEARED THAT ALL THE PIECES WERE ABLE TO BE RETRIEVED. THE PATIENT WAS STABLE DURING THE TAVR PROCEDURE. IN REGARD TO THE INJURY DUE TO WITHDRAWAL DIFFICULTY WITH BURST BALLOON, IT WAS REPAIRED WITH SUTURES.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 22045084 ↗
• MalfunctionAug 12, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A TRANSCAROTID AORTIC VALVE REPLACEMENT PROCEDURE WITH A 26MM SAPIEN 3 ULTRA RESILIA VALVE, THE BALLOON ON THE CERTITUDE DELIVERY SYSTEM RUPTURED DURING DEPLOYMENT. CALCIUM AT THE SINOTUBULAR JUNCTION WAS NOTED AND SUSPECTED TO BE THE CAUSE OF THE BALLOON RUPTURE PER PHYSICIAN. THE PHYSICIAN WAS ABLE TO PULL THE BALLOON AND DELIVERY SYSTEM INTO THE SHEATH AND REMOVE FROM PATIENT. THE PHYSICIANS DEFLATED BALLOON AND WERE THEN ABLE TO PULL IT BACK INTO THE ESHEATH+ AND REMOVED EVERYTHING AS ONE UNIT. THE VALVE APPEARED TO BE FULLY EXPANDED, AND NO POST-DILATION WAS NECESSARY. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19963663 ↗
• InjuryJan 10, 2024Burst Container or Vessel; Material Fragmentation; Difficult to Remove; Burst Container or Vessel; Material Fragmentation; Difficult to Remove

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT CASE BY TRANSAORTIC APPROACH, DUE TO SINOTUBULAR JUNCTION (STJ) CALCIUM THE CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED DURING DEPLOYMENT. THE VALVE WAS FULLY DEPLOYED. THE PHYSICIANS WERE UNABLE TO RETRIEVE THE CERTITUDE SYSTEM INTO THE SHEATH BECAUSE OF THE BROKEN BALLOON AND THE INSIDE COMPONENTS. THE CERTITUDE DID NOT SEPARATE INTO PIECES, BUT A PIECE DID COME APART AFTER THE DELIVERY SYSTEM EXITED THE BODY. THE PATIENT HAD BLOOD LOSS WHILE ATTEMPTING TO GET THE DEVICE OUT OF THE PATIENT, AND A TRANSFUSION WAS REQUIRED. DURING PRE-DECONTAMINATION OBSERVATION, IT WAS FOUND THAT THE MAJORITY OF THE INFLATION BALLOON WAS MISSING PIECES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486861 ↗
• MalfunctionOct 19, 2023Material Deformation; Material Deformation

  DURING A TAVR PROCEDURE USING A 26MM SAPIEN 3 ULTRA VALVE VIA TRANSAORTIC APPROACH, THE CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED AT THE END OF VALVE DEPLOYMENT. THE VALVE WAS FULLY DEPLOYED AND NO PVL WAS NOTED. THE BALLOON WAS RETRACTED FROM THE PATIENT SUCCESSFULLY. THE DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966065 ↗
• MalfunctionAug 13, 2021Burst Container or Vessel; Material Separation; Burst Container or Vessel; Material Separation

  AS REPORTED, DURING A TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26MM SAPIEN 3 ULTRA VALVE, THE CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED DURING VALVE DEPLOYMENT. THE VALVE WAS IN GOOD POSITION. ECHO SHOWED NO MOVEMENT OF VALVE AND GRADIENT OF 4 MM HG. DURING WITHDRAWAL OF DELIVERY SYSTEM, THE BALLOON BROKE IN HALF. THE NOSE CONE, PART OF BALLOON AND INNER GUIDEWIRE LUMEN OF DISTAL PART OF DELIVERY SYSTEM WAS IN PATIENT. THE PHYSICIAN SLOWLY PULLED THE NOSECONE AND BALLOON INTO THE SHEATH. THE SHEATH AND BROKEN BALLOON WERE TAKEN OUT OF THE PATIENT WITH NO INJURY. THE PATIENT IS IN STABLE POST PROCEDURE. THE PERCEIVED CAUSE OF THE BALLOON BURST WAS DUE TO CALCIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12319311 ↗
• InjuryApr 23, 2021Burst Container or Vessel; Difficult or Delayed Positioning; Material Rupture; Difficult to Advance; Device Dislodged or Dislocated; Burst Container or Vessel; Difficult or Delayed Positioning

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT DURING A TRANSCATHETER VALVE REPLACEMENT IN THE TRICUSPID POSITION VIA THE INTERNAL JUGULAR (IJ) VEIN, THE FAILING 27MM NON-EDWARDS SURGICAL VALVE WAS UNABLE TO BE CROSSED AND UPON WITHDRAWAL, THE 26MM SAPIEN 3 ULTRA (S3U) VALVE WAS MOVED PARTIALLY OFF THE CERTITUDE DELIVERY SYSTEM BALLOON. IT WAS DECIDED TO IMPLANT THE VALVE IN THE SUPERIOR VENA CAVA. DURING DEPLOYMENT, THE CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED. 2 BVF (BALLOON VALVULAR FRACTURE) ATTEMPTS OF THE NON-EDWARDS VALVE SURGICAL VALVE WERE MADE PRIOR TO INTRODUCING THE CERTITUDE DELIVERY SYSTEM. THEY WERE UNABLE TO ADVANCE THE 26MM CERTITUDE DELIVERY SYSTEM BEYOND THE SURGICAL VALVE DISTAL MARKERS. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, A NEW 26MM S3U VALVE AND COMMANDER DELIVERY SYSTEM WAS SUCCESSFULLY DELIVERED THROUGH A 26FR GORE DRYSEAL SHEATH VIA TRANSFEMORAL APPROACH. WHEN ATTEMPTING TO RETRIEVE THE UNDEPLOYED VALVE AND CERTITUDE SYSTEM, THE S3U VALVE PARTIALLY DISLODGED OFF THE CERTITUDE DELIVERY SYSTEM BALLOON AND IT WAS DETERMINED THAT THE SAFEST APPROACH WAS TO DEPLOY IT IN THE SUPERIOR VENA CAVA (SVC). AS ANTICIPATED, ONLY THE PROXIMAL END

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 11720239 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140031. One submission often covers many models, so check the product and lot details in each record.

• Z-0835-2019 · Jan 22, 2019 · Terminated
  Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 0
• Z-2435-2018 · Jun 11, 2018 · Terminated
  Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
• Z-0293-2018 · Jul 21, 2017 · Terminated
  Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delive